Daiichi Sankyo, Inc.
Director, Development SOP Management
Daiichi Sankyo, Inc., Trenton, New Jersey, United States,
Director, Development SOP ManagementJoin a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary:The Director, Development SOP Management is responsible for providing strategic direction, planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and related documents related to clinical trial execution.
Responsibilities:Development SOP Landscape Develop and maintain overview of Development SOP and associated document landscape including planned new documents, changes, and retirements. Create awareness of SOP updates resulting from organizational changes, regulatory requirements, CAPAs, cross functional initiatives and routine process updates. Create plans to ensure SOP updates are coordinated across functions and/or initiatives to support timely implementation while minimizing change. Identify, escalate, and plan and implement mitigations related to potential systemic gaps in the Development SOP landscape and/or processes and coordinate with the appropriate stakeholders to ensure timely remediation.
SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. Provide reviews of draft SOPs/changes from a cross functional Development point of view and provide guidance to authors to ensure regulatory compliance, consistency and connectiveness across SOPs. Implement consistent wording and standards across Development SOPs (e.g., scope description, roles and responsibilities, key terms, etc.) in partnership with Functions, SOP Authors, and the Global SOP committee. Ensure relevant stakeholders are involved at the appropriate time in the drafting and review of SOPs. Facilitate cross functional alignment prior to and during SOP review processes. Analyze SOP deviations and CAPAs to identify required SOP revisions. Work with QA, Functional Leaders, and SOP authors to ensure process deviations and/or CAPAs are appropriately utilized to document SOP related activities as required.
SOP Development Process and Reporting Recommend and implement innovative process ideas and tools to expediate SOP authorship, review and approval timelines. Develop reporting/dashboards to communicate SOP development and revision status and expected effectiveness timelines. Establish metrics and conduct trending to report on and predict future cycle times.
SOP Training Work with Development Leaders, Process Authors, Change and Enablement and Learning and Development to coordinate SOP Training and effectiveness beyond Read and Apply training in LMS.
Inspection Readiness Provide support for audits, inspections and inspection readiness activities as needed.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education:Bachelor's Degree with minimum of 10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications
Experience:10 or More Years Knowledge and understanding of GCPs and applicable global regulatory guidelines governing clinical trials preferred
Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more Development functions preferred
Direct experience in SOP authorship preferred
Experience with process improvement methodologies and proficient in creation of process maps preferred
Experience working with Quality Management systems preferred
Experience with requirements related to global health authority inspections, participation in inspection activities and finding remediation preferred
Demonstrate ability to combine attention to detail with big picture perspective preferred
Strong project management skills, experience leading projects/teams and ability to influence others without direct authority preferred
Effective and influential communication, self-management, complex problem solving, critical thinking, and organizational skills including navigating through ambiguity preferred
Experience with facilitation, negotiation and conflict resolution while preserving strong cross functional collaboration preferred
Travel:Ability to travel up to 5%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary:The Director, Development SOP Management is responsible for providing strategic direction, planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and related documents related to clinical trial execution.
Responsibilities:Development SOP Landscape Develop and maintain overview of Development SOP and associated document landscape including planned new documents, changes, and retirements. Create awareness of SOP updates resulting from organizational changes, regulatory requirements, CAPAs, cross functional initiatives and routine process updates. Create plans to ensure SOP updates are coordinated across functions and/or initiatives to support timely implementation while minimizing change. Identify, escalate, and plan and implement mitigations related to potential systemic gaps in the Development SOP landscape and/or processes and coordinate with the appropriate stakeholders to ensure timely remediation.
SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. Provide reviews of draft SOPs/changes from a cross functional Development point of view and provide guidance to authors to ensure regulatory compliance, consistency and connectiveness across SOPs. Implement consistent wording and standards across Development SOPs (e.g., scope description, roles and responsibilities, key terms, etc.) in partnership with Functions, SOP Authors, and the Global SOP committee. Ensure relevant stakeholders are involved at the appropriate time in the drafting and review of SOPs. Facilitate cross functional alignment prior to and during SOP review processes. Analyze SOP deviations and CAPAs to identify required SOP revisions. Work with QA, Functional Leaders, and SOP authors to ensure process deviations and/or CAPAs are appropriately utilized to document SOP related activities as required.
SOP Development Process and Reporting Recommend and implement innovative process ideas and tools to expediate SOP authorship, review and approval timelines. Develop reporting/dashboards to communicate SOP development and revision status and expected effectiveness timelines. Establish metrics and conduct trending to report on and predict future cycle times.
SOP Training Work with Development Leaders, Process Authors, Change and Enablement and Learning and Development to coordinate SOP Training and effectiveness beyond Read and Apply training in LMS.
Inspection Readiness Provide support for audits, inspections and inspection readiness activities as needed.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education:Bachelor's Degree with minimum of 10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications
Experience:10 or More Years Knowledge and understanding of GCPs and applicable global regulatory guidelines governing clinical trials preferred
Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more Development functions preferred
Direct experience in SOP authorship preferred
Experience with process improvement methodologies and proficient in creation of process maps preferred
Experience working with Quality Management systems preferred
Experience with requirements related to global health authority inspections, participation in inspection activities and finding remediation preferred
Demonstrate ability to combine attention to detail with big picture perspective preferred
Strong project management skills, experience leading projects/teams and ability to influence others without direct authority preferred
Effective and influential communication, self-management, complex problem solving, critical thinking, and organizational skills including navigating through ambiguity preferred
Experience with facilitation, negotiation and conflict resolution while preserving strong cross functional collaboration preferred
Travel:Ability to travel up to 5%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.